NCT01419002终止3 期
Neoadjuvant Radiotherapy in Patients With Primary Resectable Adenocarcinoma of the Pancreatic Head Plus Adjuvant Chemotherapy: a Randomized Controlled Phase III Trial
CHIR-Net1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2011年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Local recurrence free survival
研究概览
简要总结
Net-Pac investigates if radiation prior to surgical resection improves survival in patients with pancreatic head cancer without metastases.
详细描述
The trial is designed to show that neoadjuvant radiotherapy followed by surgery improves local recurrence free survival compared to surgery alone in patients with resectable adenocarcinoma of the pancreatic head.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the pancreatic head
- •Age ≥ 18 years
- •Signed informed consent
- •ECOG performance status of 0-2
排除标准
- •Curative resection is not feasible or presence of metastatic disease
- •Patients not eligible for surgery (ASA ≥ 4)
- •Participation in an other clinical trial
- •Unable or unwilling to sign the informed consent
研究组 & 干预措施
Neoadjuvant RTx
Experimental
干预措施: neoadjuvant RTx (Radiation)
Surgery
Active Comparator
干预措施: Surgery (Procedure)
结局指标
主要结局
Local recurrence free survival
时间窗: At 12 months postoperative
次要结局
- Clinical response rate (RECIST-criteria) and histological response rate(Until 1 year postOP)
- Toxicity of preoperative Radiotherapy(Start of the radiotherapy until 12 months postoperative.)
- Time to tumor progression (local and systemic)(Until 1 year postoperative)
- Percentage of surgical R0-resections in both groups(Until 10 days postoperative)
- 30-day morbidity and mortality(30 day period after the operation)
- Quality of life(Until 12 months postoperative)
- Overall survival after 1 year(Until 1 year postoperative)
研究者
研究点 (1)
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